Chronic Renal FailureNCT03397381
Outcome of Arterio-venous Fistula for Adult Hemodialysis Patients in Assiut Governorate
An observational study of Chronic Renal Failure, run by Assiut University at 1 site in Egypt.
Trial summary
identification of the factors that affect the outcome of arteriovenous fistula in chronic renal failure patients that newly established regular dialysis in Assiut Governorate 1. To study the factors that influence the outcome of AVF 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Failure
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2018to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Chronic renal Failure on regular dialysis
Who may be able to join
- all adult hemodialysis Patients in Assiut Government are eligible for enrollment if they are newly dialyzed via AVF and agree to participate in the study
Who cannot join
- Patients are not dialyzed with AVF
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Hanan
Asyut, 71515
Hanan S Mahrous, MD, 01017031500, mostafak198173@yahoo.com
Mostafa K Ahmed, MD, 01017035635, mostafaahmed15581@gmail.com
About this study
identification of the factors that affect the outcome of arteriovenous fistula in chronic renal failure patients that newly established regular dialysis in Assiut Governorate
- To study the factors that influence the outcome of AVF
- To evaluate the vascular complications of AVF as occlusion, rupture, aneurysmal dilation and hand ischemia
- Conditions
- Chronic Renal Failure
- Medical subject headings
- Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of new renal failure patients with failed arteriovenous fistula as measured with arteriovenous duplex ultrasound imaging peak systolic velocity and end-diastolic velocity in Assiut Governorate
the arteriovenous fistula will be named fail if one or more of the following
- No Doppler signal
- Ratio of peak systolic velocity at stenosis to peak systolic velocity at 2 cm beyond anastomosis (if normal)appearing >3
- Intraluminal echogenicity
- Graft walls appear collapsed
Measured: 3 years
Secondary outcomes (1)
the number deaths of renal failure patients on regular dialysis related to AVF complications in Assiut Governorate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start20 Jan 2018
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Sayed Hassan Mahrous, Assiut University
- Investigators
- Hanan S Mahrous, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397381
- Sponsor's protocol ID
- 17200155
- Status last verified
- Jan 2019
- First submitted
- 26 Dec 2017
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stolic R. Most important chronic complications of arteriovenous fistulas for hemodialysis. Med Princ Pract. 2013;22(3):220-8. doi: 10.1159/000343669. Epub 2012 Nov 2.
PubMed 23128647Lok CE. Fistula first initiative: advantages and pitfalls. Clin J Am Soc Nephrol. 2007 Sep;2(5):1043-53. doi: 10.2215/CJN.01080307. Epub 2007 Aug 16. No abstract available.
PubMed 17702726Valliant A, McComb K. Vascular Access Monitoring and Surveillance: An Update. Adv Chronic Kidney Dis. 2015 Nov;22(6):446-52. doi: 10.1053/j.ackd.2015.06.002.
PubMed 26524949Hammes M. Hemodynamic and biologic determinates of arteriovenous fistula outcomes in renal failure patients. Biomed Res Int. 2015;2015:171674. doi: 10.1155/2015/171674. Epub 2015 Oct 1.
PubMed 26495286Padberg FT Jr, Calligaro KD, Sidawy AN. Complications of arteriovenous hemodialysis access: recognition and management. J Vasc Surg. 2008 Nov;48(5 Suppl):55S-80S. doi: 10.1016/j.jvs.2008.08.067.
PubMed 19000594
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Arterio-venous Fistula for Adult Hemodialysis Patients in Assiut Governorate
- ClinicalTrials.gov ID
- NCT03397381
- Acronym / sponsor ID
- 17200155
- Conditions
- Chronic Renal Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
identification of the factors that affect the outcome of arteriovenous fistula in chronic renal failure patients that newly established regular dialysis in Assiut Governorate
- To study the factors that influence the outcome of AVF
- To evaluate the vascular complications of AVF as occlusion, rupture, aneurysmal dilation and hand ischemia
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Chronic renal Failure on regular dialysis
Key inclusion criteria (1 listed)
- all adult hemodialysis Patients in Assiut Government are eligible for enrollment if they are newly dialyzed via AVF and agree to participate in the study
Key exclusion criteria (1 listed)
- Patients are not dialyzed with AVF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the number of new renal failure patients with failed arteriovenous fistula as measured with arteriovenous duplex ultrasound imaging peak systolic velocity and end-diastolic velocity in Assiut Governorate
Time frame: 3 years
the arteriovenous fistula will be named fail if one or more of the following 1. No Doppler signal 2. Ratio of peak systolic velocity at stenosis to peak systolic velocity at 2 cm beyond anastomosis (if normal)appearing >3 3. Intraluminal echogenicity 4. Graft walls appear collapsed
1 secondary outcome
the number deaths of renal failure patients on regular dialysis related to AVF complications in Assiut Governorate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Results publication: PubMed 23128647Stolic R. Most important chronic complications of arteriovenous fistulas for hemodialysis. Med Princ Pract. 2013;22(3):220-8. doi: 10.1159/000343669. Epub 2012 Nov 2.
- Results publication: PubMed 17702726Lok CE. Fistula first initiative: advantages and pitfalls. Clin J Am Soc Nephrol. 2007 Sep;2(5):1043-53. doi: 10.2215/CJN.01080307. Epub 2007 Aug 16. No abstract available.
- Results publication: PubMed 26524949Valliant A, McComb K. Vascular Access Monitoring and Surveillance: An Update. Adv Chronic Kidney Dis. 2015 Nov;22(6):446-52. doi: 10.1053/j.ackd.2015.06.002.
- Results publication: PubMed 26495286Hammes M. Hemodynamic and biologic determinates of arteriovenous fistula outcomes in renal failure patients. Biomed Res Int. 2015;2015:171674. doi: 10.1155/2015/171674. Epub 2015 Oct 1.
- Results publication: PubMed 19000594Padberg FT Jr, Calligaro KD, Sidawy AN. Complications of arteriovenous hemodialysis access: recognition and management. J Vasc Surg. 2008 Nov;48(5 Suppl):55S-80S. doi: 10.1016/j.jvs.2008.08.067.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanan S Mahrous, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Renal Failure, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanan S Mahrous, MD (0201017031500, mostafak198173@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of new renal failure patients with failed arteriovenous fistula as measured with arteriovenous duplex ultrasound imaging peak systolic velocity and end-diastolic velocity in Assiut Governorate (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03397381, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.